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Not yet recruitingNCT07181616Updated Aug 12, 2026

Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women

An interventional study of Adapted W2W and Waitlist Control in Health Risk Behaviors, sponsored by Laneshia Conner. Not yet recruiting at 1 site in United States. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Laneshia Conner · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years and older
Sex
Female
01

Study summary

The goal of this clinical trial is to learn whether a group-based HIV prevention program can improve HIV knowledge, prevention behaviors, and testing in older Black women aged 50 and older who live in subsidized housing. The study focuses on improving how HIV prevention programs address the unique needs and life experiences of older Black women.

The main questions it aims to answer are:

Can a revised HIV prevention intervention tailored to reproductive health histories improve HIV knowledge, condom use, and testing in older Black women?

Is the intervention feasible, acceptable, and engaging for participants?

The PI will compare a group of participants receiving the Woman-2-Woman (W2W) intervention to a wait-listed control group to see if the intervention leads to better HIV prevention outcomes.

Participants will:

Join a group-based HIV prevention program designed for older Black women

Be randomly assigned to either:

Start the intervention right away, or

Join a waitlist and start the program 4 weeks later

Take part in four weekly sessions that include group discussions, education, and skill-building activities

Share information about their reproductive health histories and sexual health decisions during focus groups or surveys

Complete questionnaires at the start, after the program ends, and 4 weeks later to assess HIV knowledge, condom use, and testing behavior

This research aims to create a culturally tailored, evidence-based HIV intervention that fits the lives and needs of older Black women and can be used in future, larger studies.

02

Conditions studied

  • Health Risk Behaviors

Keywords

  • HIV
  • Health Education
  • Health Equity
03

In context

Health Risk Behaviors

60 studies on the registry are indexed under Health Risk Behaviors; 17 are open to participants now.

This study's planned enrollment of 60 is below the median of 144 across 47 interventional studies indexed under Health Risk Behaviors.

Browse Health Risk Behaviors studies →

Lead sponsor

This is the only study on the registry with Laneshia Conner as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least 50 years of age
  • A resident of Selected sites
  • A MOCA score of less than 24
  • Self-identifying as an African American woman
  • English speaking

Exclusion criteria

Exclusion Criteria:

  • Pre-menopausal
  • Cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Adapted W2W

    HIV intervention focused on aging-related HIV knowledge, identifying HIV prevention practices, and reducing HIV transmission. Intervention given in four, 2 hour educational sessions with a fifth booster session and a final follow up session.

    Behavioral: Adapted W2W

  • Active comparator
    Waitlist Control

    This group will receive the intervention 8 weeks after the W2W intervention group completes their follow-up and in the same pattern.

    Behavioral: Waitlist Control

Interventions

  • BehavioralAdapted W2W

    HIV education sessions and questionnaires.

  • BehavioralWaitlist Control

    HIV education sessions and questionnaires given 4 weeks after W2W intervention.

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Feasibility will be measured by recruitment rate (number of participants who sign the informed consent divided by those participants who meet the eligibility criteria)

    Time frame: Baseline

  2. Acceptability

    Acceptability will be measured by program satisfaction evaluations. Participants rate statements (1-5) with higher scores equating to greater satisfaction.

    Time frame: Assessed at weeks 1,2,3,4, 8 and 12

  3. Retention Rate

    Feasibility will also be measured by retention rate (number of participants who complete all 4 sessions divided by those participants who signed the informed consent)

    Time frame: Baseline (week 1) and Post-Intervention (Week 8)

  4. Change in HIV Knowledge

    HIV knowledge will be measured by the HIV-KQ-18. Scores range from 0-18 with higher scores equating to greater HIV knowledge.

    Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)

  5. Change in Condom-use self-efficacy (CUSES)

    CUSES is a 28 item scale that will assess behavioral intentions and past behavior related to feelings about purchasing, using, and negotiating use of condoms with a new partner. Each item has a 5-point response format ranging from 0 (strongly disagree) to 4 (strongly agree). After reversing negatively worded items, scores range from 0-112 (with higher scores indicating more self-efficacy).

    Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)

  6. Change in H-AGE scale

    The H-AGE scale is a gender and aging specific HIV knowledge scale with 6 items that assess participants knowledge of gender and age related issues regarding HIV. Q1 is a true/false question; Q2 \& 3 are multiple choice questions; Q4 is rating of strongly disagree (1) to strongly agree (5); Q5 is rating very comfortable (1)to very uncomfortable (5); Q6 they select one from the following (positive, negative, mixed, neutral)

    Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jul 2030, 44 months later.

Of 36 non-industry interventional studies with no phase under Health Risk Behaviors, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 44 months is above that.

Counting every sponsor, half of 37 studies reached it within 18 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2025
First posted
Sep 18, 2025
StartEst.
Nov 30, 2026
Primary completionEst.
Jul 2030
CompletionEst.
Jul 2030
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07181616
Lead sponsor
Laneshia Conner
Responsible party
Laneshia Conner (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted
Sep 18, 2025
Start date
Nov 30, 2026 (estimated)
Primary completion
Jul 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Aug 12, 2026

Study contacts

Laneshia Conner, PhD
Contact
laneshia.conner@uky.edu
859-562-3355
Laneshia Conner, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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